Eltium 50
ELTIUM 50
COMPOSITION:
Itopride hydrochloride ........................ 50 mg
Excipients q.s .................................. 1 tablet
(Lactose monohydrate, microcrystalline cellulose M101, povidone K30, magnesium stearate, sodium starch glycolate, colloidal silicon dioxide, titanium dioxide, hypromellose 606, hypromellose 615, polyethylene glycol 6000, talc).
DOSAGE FORM: Film coated tablet.
PRESENTATION: Box of 5 blisters x 10 tablets.
Box of 10 blisters x 10 tablets.
PHARMACODYNAMICS: Eltium 50 contains the active ingredient itopride hydrochloride. It increases the release of acetylcholine (ACh) through dopamine D2 receptor antagonistic actions and inhibits decomposition released ACh through its acetylcholine esterase (AChE) inhibitory action, resulting in enhancement of gastrointestinal motility.
Itopride hydrochloride has been shown to activate gastric motility, accelerate gastric emptying and reduce vomiting.
PHARMACOKINETICS: Itopride hydrochloride is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma levels are reached after 30 - 40 mins after 50 mg of itopride hydrochloride. The half-life is about 6 hours. The drug is metabolized by the liver and excreted primarily in the urine. Approximately 96% of itopride hydrochloride is bound to plasma proteins after a single oral dose of 100 mg itopride hydrochloride in healthy people with fasting condition.
INDICATIONS: Gastrointestinal symptoms in chronic gastritis (bloated feeling, abdominal distension, upper abdominal pain, anorexia, heartburn, nausea and vomiting).
CONTRAINDICATIONS:
Known hypersensitivity to the drug or any of the excipients.
Pregnant women and breast-feeding mothers.
An increase in gastrointestinal motility could be harmful e.g gastrointestinal hemorrhage, mechanical obstruction or perforation.
PRECAUTIONS: The drug should be used with caution since it enhances the action of acetylcholine.
The drug should not be consumed continuously for an extended period when no improvement of gastrointestinal symptom is observed.
Elderly patients should be carefully monitored during treatment period. If adverse reactions are evident, appropriate measures such as dose reduction or discontinuation of therapy should be implemented.
Patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
PREGNANCY AND LACTATION: The drug should not be indicated to pregnant women and breast-feeding mothers.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The drug can cause headache, dizziness (rate of £ 0.1%); use with caution in machine operators, drivers, workers at height, and other cases.
INTERACTIONS: There is a possibility of reducing the action of the drug that activates gastrointestinal motility when used concurrently with anticholinergic agents, including tiquizium bromide, scopolamine butylbromide, timepidium bromide, etc.
ADVERSE EFFECTS:
Shock and anaphylactoid reactions (incidence unknown): If any signs of shock and anaphylactoid reaction such as hypotension, dyspnea, larynx edema, urticaria, pallor and diaphoresis, etc. are observed, administration of the drug should be discontinued and appropriate measures should be taken.
Hepatic function disorder and jaundice (incidence unknown): Hepatic function disorder and jaundice with increased AST (GOT), ALT (GPT) and g - GTP, etc. may occur and the patient should be carefully monitored. If such abnormalities are observed, administration of the drug should be discontinued and appropriate measures should be taken.
Other adverse reactions:
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5% > ≥ 0.1 % |
≤ 0.1 % |
Incidence unknown(1) |
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Hypersensitivity(2) |
Rash, redness, itching, etc. |
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Extrapyramidal symptoms(2) |
Tremor, etc. |
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Endocrine (2) |
Increased prolactin, etc. |
Gynecomastia, etc. |
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Hematologic (2) |
Thrombocytopenia, leucopenia, etc. |
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Gastrointestinal |
Diarrhea, constipation, abdominal pain, etc. |
Nausea, increased saliva, etc. |
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Psychoneurologic |
Headache, irritated feeling, sleep disorder, dizziness, etc. |
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Hepatic |
Increased AST (GOT), increased ALT (GPT) |
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Renal |
Increased BUN, increased creatinine, etc. |
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Others |
Chest or back pain, fatigue, etc. |
(1): Incidence is unknown due to spontaneous reports.
(2): If any abnormality is observed, appropriate measures, such as discontinuation of the drug, should be taken.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: There have been no reported cases of overdose. In case of overdose, appropriate measures of gastric lavage and symptomatic treatment should be taken.
DOSAGE & ADMINISTRATION:
Adults: 1 tablet 3 times daily orally, taken before a meal. The dose can be reduced depending on the age and condition of each patient.
Or as directed by the physician.
Keep out of the reach of children.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescription only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions:
Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.